Sinkiewicz W, Glazer R D, Kavoliuniene A, Miglinas M, Prak H, Wernsing M, Yen J
Department of Clinical Bases of Physiotherapy, University Nicolaus Copernicus in Torun, Poland.
Curr Med Res Opin. 2009 Feb;25(2):315-24. doi: 10.1185/03007990802630588.
To demonstrate additional BP-lowering effects of amlodipine/valsartan combination in patients whose BP was not adequately controlled on valsartan alone.
This was a multi-centre, randomised, double-blind, active-controlled study in patients with essential hypertension. After a washout period followed by a single-blind valsartan 160 mg run-in period, patients with mean sitting diastolic blood pressure (DBP) >or= 90 mmHg and < 110 mmHg were randomised to receive amlodipine/valsartan (10/160 mg or 5/160 mg o.d.) or valsartan (160 mg o.d.) for 8 weeks.
NCT00170963 MAIN OUTCOME MEASURES: Primary efficacy variable was change from baseline in mean DBP at study end. Secondary efficacy variables included change from baseline in mean sitting systolic blood pressure (SBP), responder rate (mean DBP < 90 mmHg or >or= 10 mmHg reduction from baseline), and DBP control rate (mean DBP < 90 mmHg). Safety was also assessed.
Of 1136 patients enrolled in single-blind phase, 947 (mean age: 54.6 years) were randomised. Statistically significantly greater reductions in mean SBP/DBP were observed in both amlodipine/valsartan combinations (10/160 mg: 14.3/11.5 mmHg, 5/160 mg: 12.2/9.6 mmHg; both p < 0.0001) compared to valsartan 160 mg (8.3/6.7 mmHg). The 10/160 mg combination (p < 0.05) showed statistically significantly greater reductions in mean SBP/DBP compared to 5/160 mg (p < 0.001). Responder rates were higher in both combination therapy groups (10/160 mg: 81% [p < 0.0001]; 5/160 mg: 68% [p = 0.0018], respectively) compared to monotherapy (57%). Peripheral oedema was the most frequent adverse event, reported in amlodipine/valsartan 10/160 mg (9.1%), 5/160 mg (0.9%), and valsartan 160 mg (1.3%).
The combination of amlodipine/valsartan in this 8-week double-blind study provided additional BP control and was well-tolerated in patients inadequately controlled with valsartan monotherapy.
证明氨氯地平/缬沙坦联合用药对单用缬沙坦血压控制不佳患者的额外降压效果。
这是一项针对原发性高血压患者的多中心、随机、双盲、活性药物对照研究。在经过洗脱期，随后是单盲缬沙坦160mg导入期后，平均坐位舒张压（DBP）≥90mmHg且＜110mmHg的患者被随机分组，接受氨氯地平/缬沙坦（10/160mg或5/160mg每日一次）或缬沙坦（160mg每日一次）治疗8周。
NCT00170963
主要疗效变量为研究结束时平均DBP相对于基线的变化。次要疗效变量包括平均坐位收缩压（SBP）相对于基线的变化、有效率（平均DBP＜90mmHg或较基线降低≥10mmHg）以及DBP控制率（平均DBP＜90mmHg）。同时评估安全性。
在单盲阶段入组的1136例患者中，947例（平均年龄：54.6岁）被随机分组。与缬沙坦160mg（8.3/6.7mmHg）相比，两种氨氯地平/缬沙坦联合用药组（10/160mg：14.3/11.5mmHg，5/160mg：12.2/9.6mmHg；均p＜0.0001）平均SBP/DBP降低幅度在统计学上显著更大。10/160mg联合用药组（p＜0.05）与5/160mg联合用药组相比，平均SBP/DBP降低幅度在统计学上显著更大（p＜0.001）。两个联合治疗组的有效率均高于单药治疗组（10/160mg：81%[p＜0.0001]；5/160mg：68%[p = 0.0018]），单药治疗组为57%。外周水肿是最常见的不良事件，在氨氯地平/缬沙坦10/160mg组（9.1%）、5/160mg组（0.9%）和缬沙坦160mg组（1.3%）均有报告。
在这项为期8周的双盲研究中，氨氯地平/缬沙坦联合用药可进一步控制血压，且对单用缬沙坦治疗控制不佳的患者耐受性良好。
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